Vena cava filters are used to capture potentially fatal blood clots at an anatomical location where they may pose less risk of pulmonary emboli for the patient. Since the vast majority of pulmonary emboli originate from the lower body, filters are mainly placed in the inferior vena cava.
The optimal filter device should capture blood clots while ensuring continued blood flow through a blood vessel of a patient. Studies have demonstrated that a conical filter configuration provides optimal filtering efficiency. Conical designs force clots toward the center of the filter, allowing blood flow passage around the clot. Continued blood flow through the filter when a clot load is present ensures that captured clots are exposed to the lysing action of the blood flow.
Although conical filter configurations currently available on the market provide optimal filtering capabilities, these designs are prone to tilting and misalignment. When not in proper alignment, filtering ability is compromised. The central conical portion of the filter may tilt to the extent that it becomes embedded in the vessel wall. In retrievable filter designs, a retrieval hook is typically located at the central apex of the filter cone. If the filter tilts, this may result in the retrieval hook coming in contact with the vessel wall, making retrieval efforts more difficult or even preventing removal of the filter device. Tilting may also cause disruption of laminar blood flow, decrease in lysing of captured clots, or thrombus build-up and occlusion of the filter.
To maintain alignment of conical filters, centering or alignment features have been incorporated into filter designs. Centering has been accomplished by the use of free arms that extend radially outward from the filter to contact the vessel wall at a plane spaced apart from the contact point of the filter legs. While free arm centering designs ensure that the conical filtering section generally remains centered within the vessel, these designs are disadvantageous in that the free arms are prone to vessel perforation, fracture and in some cases misalignment due asymmetrical spacing of the free arms. Moreover, occasionally, when attempting to snare the alignment arms, they will become bent upwards making the retrieval of the filter even more difficult.
To overcome problems with free arm designs, closed loop alignment structures have been utilized. A closed loop alignment structure is comprised of alignment ribs that are connected at each end to a hub or other filter element and thus have no free standing arms. The non-perforating curved portion of each alignment rib may rest against the vessel wall to provide a centering function. These closed loop centering structures are less prone to fracture and will not perforate a vessel wall.
Although overcoming problems associated with free arm centering structures, filters designed with closed loop structures are difficult to retrieve from the vessel, particularly if a portion of the alignment structure has become incorporated into the vessel wall by endothelial overgrowth. Endothelial overgrowth may occur at any point where the filter contacts the vessel wall. Over time, the endothelial overgrowth may partially or completely encapsulate any portion of the filter in contact with the wall. This process is called neointimal hyperplasia and occurs as early as two weeks after implantation. The vessel wall responds to a foreign presence such as a filter by increased smooth muscle cell growth and neointimal thickening at the contact points. A band of endothelial tissue over a filter segment makes retrieval of the filter from the vessel more difficult, especially those filters designed with a closed loop configuration.
Accordingly, it is desirable to provide a retrieval blood clot filter with a filtering configuration and a centering structure that can be easily retrieved from the vessel even in the presence of endothelial growth over portions of the centering structure. The filter should be designed to allow percutaneous removal without significant trauma or damage to the vena cava wall even after neointima overgrowth has embedded those portions of the filter that are in contact with the vessel wall.